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GMDN Agency Flooded With Requests For Device Terms Ahead Of US UDI Deadline

Medical device-makers rushing to meet US FDA's upcoming Sept. 24 Unique Device Identification deadline for class II products are flooding the Global Medical Device Nomenclature Agency with requests for new or revised terms that they need to correctly add their products to FDA's UDI database.

Policy & Regulation United States Medical Device

Intuitive Sues Ethicon Over Sales Rep Non-Compete

Intuitive is suing to block Ethicon’s attempt to prevent Intuitive from hiring a former Ethicon sales rep. The device-maker says Ethicon’s attempt to enforce a non-compete agreement is void under California state law.

United States Commercial Legal Issues

When Do Device Companies Declare Payments To Professionals And Health-Care Organizations In Europe?

Europe recently saw a wave of disclosures published by pharmaceutical trade associations revealing the transfers of value made by companies to health-care professionals and organizations. In this article, attorneys at the law firm Baker & McKenzie – Julie Yeni, Julia Gillert, Chloe Cornet and Elina Angeloudi – discuss how the growing trend toward imposing greater transparency in the relationships between the health industry and health-care professionals continues, and what it will mean for the medical device sector in different countries across Europe and in Saudi Arabia.

Europe Legal Regulation

Device Week – August 26, 2016

On this week's Medtech Insight podcast: many manufacturers are unprepared for US FDA's upcoming Unique Device Identification deadline; two new guidances from FDA finger benefit-risk and patient-preference issues; Fractyl Labs' Revita system shows promise in the fight against type 2 diabetes.

Regulation Medical Device Legislation
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Policy & Regulation

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Industry, US FDA Strike $1Bn Deal After Contentious User-Fee Negotiations

FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.

Policy & Regulation Regulation Legislation

Manufacturers Scramble To Meet Looming Unique Device Identification Deadline – But Too Many Are Unprepared

US FDA and device industry experts are concerned that too many firms are woefully unprepared for, and undereducated about, the agency's Unique Device Identification program. A recent industry survey appears to bear this out: A whopping 85% of respondents say they're not ready for the upcoming UDI compliance deadline of Sept. 24 for makers of class II products. Meanwhile, firms asking for UDI exceptions for their devices are waiting an inordinate amount of time for FDA to come to a decision, in part because the agency simply doesn't know how to publicly disclose the exemptions, UDI guru Jay Crowley says. Also: experts mull over the agency's latest UDI guidance; FDA explains why using an HL7 UDI submission option for its GUDID database isn't a good idea for every firm; and Crowley discusses what the UDI landscape will look like in 2020.

Medical Devices Quality Control Manufacturing Quality

Latest From Policy & Regulation

US FDA: Better Safety Warnings Needed On Infusion Pumps

Adverse-event reports tied to low-flow syringe infusion pumps have led FDA to recommend modifications to the pumps’ safety labeling. The agency doesn’t expect the changes to trigger a new 510(k) requirement.

Medical Device Regulation

Chembio Wins $13.2M US BARDA Contract To Develop POC Zika Tests

HHS and its subagency Biomedical Advanced Research and Development Authority (BARDA) has put together additional funding to award Chembio Diagnostic Systems $13.2m to develop and commercialize the firm's rapid point-of-care Zika test, a mere two weeks after the agency said it only had enough funds for Zika vaccine development.

United States Medical Device

Final Guidance Encourages Use Of Patient Preference In Device Applications

US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.

Regulation Legislation

Commercial

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IBA's Soaring Sales Underline Proton Therapy Demand

Ion Beam Applications continues to defend its lion's share of the proton therapy market, reporting double-digit topline growth for the first half of 2016 in spite of challenges in its more traditional radiotherapy offering.

Medical Device Cancer Commercial

Latest From Commercial

Getinge Ousts CEO Mid-Restructure

Getinge is looking for a new CEO after deciding to jettison Alex Myers from the helm, less than 18 months after he took up the top executive role.

Surgery Companies

NSF International Names Former FDA Deputy Director As Executive VP

Regulatory compliance consulting firm NSF International recently appointed Heather Howell, a former deputy director for communications within US FDA’s device center, to serve as executive VP of training and internal quality management systems for the firm’s medical device group in DC.

Commercial Medical Device

Start-Up Spotlight: MagDent, Electromagnetic Healing Cap For Dental Implants

Israeli start-up MagDent Ltd. has developed a miniaturized electromagnetic healing cap designed to stimulate and improve bone formation at the site of dental implants.

Dental Oral Innovation

Clinical R&D

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Fractyl's Novel Diabetes Treatment Clears First Hurdle In Clinical Trial

The first-in-human study of Fractyl's Revita duodenal mucosal resurfacing system shows significant short-term improvement in hyperglycemia in patients with type 2 diabetes, with few adverse events.

Research & Development Clinical Trials Diabetic Care

Latest From Research & Development

ZipLine's Closure Device Beats Sutures In Pediatric Cardiac Surgery Trial

The Zip surgical skin closure system does not require FDA clearance, but the company is sponsoring a series of trials to demonstrate how it is a faster and less painful approach to healing surgical incisions.

Research & Development Innovation

Final Guidance Encourages Use Of Patient Preference In Device Applications

US FDA released a final guidance aimed at helping sponsors and other stakeholders interested in using patient-preference information to make their case for a device application. The agency has decided to keep its labeling recommendation in the final guidance despite industry objections.

Regulation Legislation

Arch Therapeutics Closes In On CE Mark For Novel Blood Control Agent

Securing the CE mark for its topical hemostatic agent has taken Arch Therapeutics longer than expected, but the company now predicts filing for a CE mark by the end of 2016, and is looking for a partner to help commercialize it in Europe.

Dermatology Clinical Trials
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